A Dose-Determination Study of Sugammadex as a Rocuronium Decurarization Agent in Children Under 2 Years of Age

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Caen Normandie

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Trial duration

18 May 2026 → ongoing

Decision date (initial)

2025-11-12

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

CHU CAEN Normandie

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Dose response

Dose–response study aimed at comparing, with the recommended adult dose (0.6 mg/kg), the doses of sugammadex required to achieve complete reversal of neuromuscular block (TOFr > 90% assessed by electromyographic monitoring) in children under 24 months of age who received rocuronium.

Secondary objectives 5

1. Compare between the 3 age groups (<6 months, [6-12] months, ]12-24[months): the doses of sugammadex necessary to obtain complete decurarisation, the percentage of subjects for whom the necessary dose was lower than the recommendations in the adult population and the percentage of subjects for whom the necessary dose was higher than the recommendations in the adult population.
2. Describe the temporal evolution of the depth of curarisation during the decurarisation procedure in children aged < 24 months.
3. To detect the possible occurrence of electrical or clinical recurarisation phenomena during the decurarisation procedure in children aged < 24 months and to assess their association with: the initial intensity of the block, the total dose of rocuronium administered and the time interval between the last dose of rocuronium and the first dose of sugammadex.
4. To determine the incidence of recurarisation (by definition: reappearance of curarisation after documented complete decurarisation) within 60 minutes of sugammadex administration, in children aged < 24 months.
5. To identify adverse events associated with the administration of sugammadex, such as recurrialisation or drug hypersensitivity.

Conditions and MedDRA coding

Non-urgent non-cardiac surgical procedure or relative emergency >12h that will require curarisation with rocuronium and decurarisation with sugammadex

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Boys and girls aged < 24 months.
2. American Society of Anesthesiologists (ASA) Physical Status Classe 1 ou 2.
3. Non-urgent non-cardiac surgical procedure or relative emergency >12h which will require curarisation with rocuronium and decurarisation with sugammadex.
4. Surgical procedure for neuromuscular monitoring of the adductor muscle of the thumb.
5. Beneficiary of a social security system
6. Signature of informed consent by the holder(s) of parental authority
7. French-speaking holder(s) of parental authority

Exclusion criteria 9

1. Emergency to be managed in the operating theatre within < 12 hours.
2. Children weighing over 20 kg
3. Premature infant: < 37 weeks gestational age at birth.
4. Neuromuscular pathology suspected or diagnosed at the time of surgery.
5. Children suspected of having or with a family history of malignant hyperthermia.
6. Children suspected of having or having an allergy to the drugs used in the study (rocuronium, sugammadex) or to one of their respective excipients.
7. Child who will benefit from mechanical ventilation after the surgical procedure.
8. Children receiving, at the time of inclusion, regular treatment with drugs that interfere with the treatments used in this study: aminoglycosides, lincosamides, polymyxins, quinidine, magnesium salts, phenytoin, carbamazepine.
9. Parents who are minors, under guardianship or trusteeship

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Total dose of sugammadex, in mg/Kg, to obtain complete decurarisation: TOFc 4/4 and TOFr ≥ 90%. The total dose is obtained by adding the sub-doses of 0.2 mg/Kg administered cumulatively every 3+/- 1 minute to each child until a TOFr >90% is obtained.

Secondary endpoints 9

1. Total dose of sugammadex administered below the recommendations for the adult population: yes / no.
2. Total dose of sugammadex administered greater than the recommendations for the adult population: yes / no.
3. Measurements of curarisation levels (TOFc and, where appropriate, TOFr) before the first injection and after each new injection of sugammadex.
4. ˗ Occurrence of recurarisation phenomena during the decurarisation procedure: yes / no. At each decurarisation measurement, a recurarisation phenomenon was defined as: - A decrease of at least 2 units in TOFc, for subjects who had a TOFc < 4/4 at the previous time; - A gross decrease of at least 20% in TOFr or a return to a TOFc < 4/4, for subjects with a TOFc = 4/4 at the previous time.
5. Intensity of initial block depth: TOFc < 2/4, TOFc ≥ 2/4.
6. Total dose of rocuronium, in mg/Kg (induction + possible re-administrations).
7. Time (in minutes) between the last administration of rocuronium and the first administration of sugammadex.
8. ˗ Occurrence of post-complete recurarisation, up to 60 minutes after the last administration of sugammadex: yes / no. A recurarisation is defined by the measurement of a TOFc < 4/4 or a TOFr < 90% after having observed a TOFr> 90%.
9. Occurrence of adverse events related to the administration of sugammadex: recurarisation, respiratory events on awakening or in the ICU, drug hypersensitivity.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Caen Normandie

Sponsor organisation

Centre Hospitalier Universitaire De Caen Normandie

Address

Avenue De La Cote De Nacre, Cs 30001 Cs 30001

City

Caen Cedex 9

Postcode

14033

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Caen Normandie

Contact name

Investigateur Coordinateur

Public contact point

Organisation

Centre Hospitalier Universitaire De Caen Normandie

Contact name

Investigateur Coordinateur

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications